Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine
All patients in this trial will receive the investigational (chemotherapy) drug at an
optimal dose as determined by previous clinical trials. The investigational drug is given
through a vein once every three weeks. This drug prevents tumor cells from dividing, so
they may stop growing or die.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
ICD CSD
Study Director
Sanofi
United States: Food and Drug Administration
EFC6088
NCT00087958
August 2004
April 2009
Name | Location |
---|---|
Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |